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Administered by: Other Purchased by: Other
Life Threatening? No
Write-up: This female subject was enrolled in an prophylactic double blind study. On 16 may 2005 and 17 June 2005, the subject received the 1st and 2nd dose of Gardasil (IM left deltoid) or Havrix (IM left deltoid). This subject received Havrix (lot DHVA817B9). The child''s mother, who is the study subject, was exposed to the vaccine before conception (see case # B0401628A for more details). On 23 March 2006, after 40 weeks of pregnancy, the subject gave birth to a healthy female infant weighing 2.7 Kg with an unknown Apgar score, by normal vaginal delivery. On 06 July 2007, two years after the 2nd dose of Blinded vaccine, the child developed cystic teratoma. The child was hospitalised. The event resolved on 14 August 2007. The investigator considered that there was a reasonable possibility that the cystic teratoma may have been caused by the investigational product and that the event was possibly due to genetic/developmental abnormalities. Investigator comments: Patient''s mother received 2 doses of investigational product. However, 76 days after the second dose of vaccine the patient''s mother conceived. Her antenatal course was unremarkable, and she delivered on 23 March 2006 via spontaneous vaginal delivery. No report or complications/problem. The patient is full term with good cry after delivery and weigh 2.7 Kg. The patient is asymptomatic, until on 06 July 2007, while the subject is changing the patient''s diaper she noted irregularity and palpable mass on patient''s abdomen. The following day, she consulted to a hospital wherein ultrasound and CT scan both confirmed the presence of mass. On 14 August 2007, the patient underwent exploratory laparotomy, salphingo-oophorectomy, right. The course of hospital stay was unremarkable and she was discharged on 17 August 2007 improved and asymptomatic. At present the patient is stable, well-nourished. The suprapubic incision was healed. The subject denies any subjective complains from the patient. A repeat ultrasound 6 months post-operative was also advised.
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